WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices

WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices

The US FDA medical device classification scheme presents some unique challenges for new technology. With a system based on equivalence, manufacturers of new and novel devices face a rigorous market entry process usually reserved for high-risk, Class III devices. However, some novel devices qualify for the FDA de novo process, which allows products to enter the market as Class I or Class II depending on their risk to users and patients.

In this webinar, Audrey Swearingen, RAC will discuss the benefits and criteria of the US FDA de novo program and how qualifying device companies can pursue this pathway to the US market. You will learn:

• What is the de novo process?
• How to determine if it is applicable to your device
• Communicating with the FDA via the Pre-Submission program
• Content of a de novo application
• FDA review process

ABOUT THE PRESENTER:
Audrey Swearingen, RAC (US) is the Regional RA Manager at Emergo by UL’s Austin, Texas headquarters. With over 20 years of experience in medical device regulatory affairs, Audrey’s areas of focus include US FDA device premarket registration, device labeling and promotion compliance, and risk assessment. Other areas of expertise include FDA human tissue regulations, as well as European CE marking and Canadian device license applications.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.